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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / March 2026 / K252401

510(k) cleared

implaFit® short stems

Implantcast GmbH · Mar 12, 2026 · K252401

FDA cleared the implaFit® short stems from Implantcast GmbH on Mar 12, 2026 under K252401, a traditional 510(k). The device falls under product code LZO, Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, regulated at 21 CFR 888.3353 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jul 31, 2025. The decision came 224 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Implantcast GmbH has 2 other decisions in the tracker over the last 12 months: K252451 (EPORE® XO cup system), K260037 (implantcast Packaging System Update).

Questions & Answers

What did FDA clear under K252401?

K252401 is the FDA 510(k) for implaFit® short stems, submitted by Implantcast GmbH. FDA's decision date was Mar 12, 2026, under product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented).

Who makes the implaFit® short stems?

Implantcast GmbH, based in Buxtehude, is the applicant of record for K252401.

How long did the K252401 review take?

FDA received the submission on Jul 31, 2025 and issued its decision on Mar 12, 2026, 224 days later.

← All decisions in March 2026

Sources